# K070443: Intracept BI-Polar RF Probe, Model 04814

- Pathway: 510(k) (Traditional)
- Applicant: Relievant Medsystems, Inc.
- Decided: Oct 5, 2007 after 232 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991218 (1999). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994344: Neurotherm RF Cannula, Rocket Medical Plc (2000) Summary page 1.
- K070711: Incircle BI-Polar RF Ablation System, Rfa Medical, Inc. (2007). Cleared while this submission was under review Summary page 1.
- K043442: Stryker RF Coaxial Bipolar Electrodes & Cannulae, Stryker Instruments (2005) Summary page 1.

## Most influential descendants
- K083856: Intracept Flexible BI-Polar RF Probe and Curved Instrument Set, Models: FG0018, FG0026 (2009), 0 descendants of its own
- K082954: Encage Bipolar RF Probe (2008), 0 descendants of its own

## Indications for use
The INTRACEPT Bi-Polar RF Probe and Instrument Set is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

Source page: https://510kreport.com/device/K070443
Methodology: https://510kreport.com/methodology